Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care (MADCO-PC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01993836
First received: November 15, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.


Condition Intervention Phase
Alzheimers Disease
Postoperative Delirium
Post Operative Cognitive Dysfunction
Drug: Total intravenous anesthesia with propofol
Drug: General anesthesia with isoflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Perioperative CSF Tau/Abeta ratio change [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    We will measure the perioperative change in the CSF tau/Abeta ratio from the start of anesthesia/surgery to 24 hours later.

  • Continuous cognitive index score change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will examine the difference in the continuous cognitive index score over time in the subjects treated with propofol versus those treated with isoflurane.

  • Assess the correlation between perioperative change in CSF Markers of Alzheimers Disease and perioperative cognitive change. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    We will assess the magnitude of the pearson correlation coefficient for the relationship between perioperative change in CSF Markers of Alzheimers Disease and the perioperative change in the continuous cognitive index score.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total Intravenous Anesthesia with Propofol
Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
Drug: Total intravenous anesthesia with propofol
Active Comparator: General anesthesia with Isoflurane
Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
Drug: General anesthesia with isoflurane

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgical patients 60 years of age or older
  • Surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)
  • English speaking ability.
  • Ability to give informed consent

Exclusion Criteria:

  • Inmate of a correctional facility (i.e. prisoners).
  • Pregnancy
  • Documented or suspected family or personal history of malignant hyperthermia.
  • Patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993836

Contacts
Contact: Miles Berger, MD, PhD miles.berger@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Miles Berger, MD, PhD       miles.berger@duke.edu   
Contact: Carlos Conde       carlos.conde@duke.edu   
Principal Investigator: Miles Berger, MD, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Miles Berger, MD, PhD Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01993836     History of Changes
Other Study ID Numbers: Pro00045180
Study First Received: November 15, 2013
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
isoflurane
propofol
total intravenous anesthesia
inhaled anesthetic
volatile anesthetic
anesthesia
delirium
Post Operative Cognitive Dysfunction
Alzheimer's Disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation
Delirium
Alzheimer Disease
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on September 16, 2014